Background: There is significant data to show that vascular endothelial growth factor (VEGF) is important in the development and progression of CLL. Bevacizumab (B) is an anti-VEGF monoclonal antibody associated with improvement in progression free survival (PFS) when combined with chemotherapy in pts with solid malignancies. FCR is the most active chemoimmunotherapy in treatment of CLL. We report data on a phase II trial combining FCR-B and comparing the results to those seen in a trial with FCR for pts with relapsed CLL (Badoux et al. Blood, March 2011). Methods: FCR consisted of F: 25 mg/m² and C: 250 mg/m² on D2-4; R: 375 mg/m² on D1 (for the first course) and 500 mg/m² for courses 2-6, every 4 weeks for 6 courses. FCR-B consisted as above for FCR and (B) 10 mg/kg was given on D3 of each cycle. Indications for treatment and response assessment were according to 1996 NCI-WG guidelines for both groups. Results: Baseline characteristics, complete remission (CR), overall response rate (ORR), PFS and OS of relapsed CLL pts are shown (Table). Conclusions: In relapsed pts with CLL, FCR-B showed a trend toward improved PFS compared to FCR.

Characteristics	FCR-B (%)[range]	FCR (%)[range]	P-value
N	62	284
Median age, yrs	64 [30-84]	60 [31-84]
Median # of prior treatments	2 [1-5]	2 [1-10]
Alkylating agent and (F) refractory	5 (8)	33 (11)
Prior exposure to FCR	52 (84)	78 (27)
Rai stage
0-II	26 (42)	154 (54)
III	9 (14)	34 (12)
IV	27 (44)	96 (34)
Karyotype/FISH
Diploid/13q-	22 (36)	97 (34)
11q-	25 (40)	16(6)
+ 12	3 (5)	13 (5)
Complex	1 (2)	22 (8)
Abn 17p	11 (18)	20 (7)
Others	0	14 (5)
Response
CR	13 (21)	85 (30)
ORR	44 (71)	210 (74)
Overall	Median (mo) [95% CI]
PFS	34 [Not reached (NR)]	23 [18-27]	Not significant (NS)
OS	NR	47 [40-53]	NS
Prior chemoimmunotherapy (FCR)
PFS	34 [16-52]	20 [17-22]	NS
OS	38 [NR]	43 [36-49]	NS